GOG-0277

Terminated

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A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma

Principal Investigator

Martee Hensley

Status

Terminated

Open to Accrual

June 4, 2012

Closed to Accrual

September 20, 2016

Closed to Accrual & Treatment

July 19, 2017

Terminated

February 9, 2019


Disease Site

Gynecologic [GY] Uterine Corpus

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin compared to patients assigned to observation.

Patient Population

Patients with high risk uterine LMS, FIGO stage I (confined to corpus +/- cervix).  Patients with known uterine serosa involvement are not eligible.  Patients should have had, at least, a complete hysterectomy (including removal of the cervix).   Bilateral salpingo-oophorectomy is not required.  

Target Accrual

216

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.